How to reconstitute Sermorelin

Before you start

The vial sold here holds 10 mg of sermorelin as a dry powder; the diluent is a separate catalog item. The approved Geref diagnostic was also a freeze-dried powder, at 50 mcg per vial, so a 10 mg vial holds 200 times that amount.¹ No current label gives a mixing volume: Drugs@FDA offers no Geref label, and DailyMed lists no sermorelin labels.²³ The diluent volume is therefore a lab choice, and the math below shows what each choice gives.

This page covers lab handling only. The compound itself is described in What is Sermorelin?, and the general method for any peptide vial is in How to reconstitute a peptide vial.

Supplies

These are separate items in the catalog:

• Bacteriostatic Water, the diluent.
• 3mL Syringe, Luer-Lok Tip and an 18G 1-Inch Needle, for drawing and adding the diluent.
• Insulin Syringes (Pack of 10), for measuring small volumes of the solution.
• Alcohol Swabs (Pack of 2), for wiping vial stoppers.

Each supplies page covers that item's storage and disposal. The full range is under Peptide supplies.

One maker's label describes Bacteriostatic Water for Injection, USP, as sterile water with 0.9% or 1.1% benzyl alcohol as a preservative, in a multiple-dose container.¹¹ The same label warns that some drugs are incompatible with benzyl alcohol; no compatibility data for sermorelin were found.¹¹

Lab steps

1. Check the vial label: compound, amount, lot, and an intact seal.
2. Choose the diluent volume from the concentration your lab method needs (see the math below), and write it down.
3. Wipe the stoppers of the peptide vial and the diluent vial with a fresh alcohol swab, and let them dry.
4. Draw the chosen volume of bacteriostatic water with the 3 mL syringe and 18G needle.
5. Add the diluent slowly, aiming the stream at the inside wall of the vial rather than straight onto the powder, as one approved freeze-dried product's label advises to prevent foaming.¹²
6. Swirl gently until no powder remains. Do not shake: one such label warns that shaking or vigorous mixing makes the solution cloudy.¹²
7. Check that the solution is clear, with no particles or discoloration.¹¹ If it is not, or powder will not dissolve, set the vial aside and record it.
8. Label the vial with the date, the volume added and the resulting concentration.
9. Store the vial as described below, and log each time the stopper is punctured.

Sterility matters at every step: the bacteriostatic water label calls for aseptic technique on every entry into and withdrawal from a container.¹¹ Compounded lyophilized sermorelin has been recalled for lack of sterility assurance.⁷

Concentration math

Three formulas cover the arithmetic:

• Concentration (mg/mL) = amount in the vial (mg) / diluent volume (mL)
• Micrograms (mcg) = milligrams (mg) x 1,000
• Volume to measure (mL) = amount wanted / concentration

Worked example for a 10 mg vial, arithmetic only:

More diluent gives a weaker solution and a larger volume for the same amount. A volume above 3 mL takes more than one draw with the 3 mL syringe. If a syringe is marked in units rather than mL, the Peptide units converter converts between them. The Reconstitution calculator and Peptide calculator run these formulas for any vial and volume. None of these numbers is a dose.

Volume for a set portion

The third formula runs the other way. At 5 mg/mL (10 mg in 2 mL), a 2.5 mg portion, one quarter of the vial, is 2.5 / 5 = 0.5 mL. At 4 mg/mL (10 mg in 2.5 mL), the same portion is 2.5 / 4 = 0.625 mL. A lab that splits a vial into equal portions can check the plan the same way: four portions of 0.5 mL add back to the full 2 mL.

Check the arithmetic

Concentration times volume should return the vial amount: 5 mg/mL x 2 mL = 10 mg. Rounding adds small errors. Ten divided by 3 is 3.333 and repeating, and 3.33 mg/mL x 3 mL = 9.99 mg, so keep the unrounded value in the records.

The math assumes the vial holds its labeled amount of peptide. A peptide maker notes that peptide content must be considered when preparing a solution of defined concentration, because a powder may be only 70 to 90% peptide by weight, the rest being counter-ions and moisture.¹³

Common slips

• Mixing up mg and mcg changes a number by a factor of 1,000.
• Reading a syringe marked in units as if it were marked in mL. Check the markings first, then convert with the units converter.
• Forgetting that the concentration is fixed once the diluent is in. Adding more diluent later lowers it, and the vial label must then be updated.

Storage

Sermorelin-specific storage data exist only for the approved product. FDA accepted stability data supporting a 24-month shelf life for Geref powder stored at 7 C, up from 12 months.¹ Storage after mixing is unconfirmed, because the Geref label is not available.² No independent stability data for the research vial were found.

General peptide guidance fills part of the gap. One peptide maker advises storing freeze-dried peptides below -15 C, and keeping peptide solutions in frozen aliquots, since long-term storage in solution is not recommended.¹³ It adds that peptides containing methionine, asparagine or glutamine have a limited shelf life; sermorelin's sequence contains all three.¹³¹⁴ Record the mixing date and concentration on the vial, and follow How to store peptides for general handling.

Routes in published studies

On the common question of sermorelin injection sites, this is what the studies report. Human studies gave sermorelin by injection under the skin, by injection into a vein, by continuous infusion and as a nasal spray.⁴⁸⁹ In the 110-child Geref trial, the injection was given under the skin once daily at bedtime.⁵ None of the studies reviewed here compared sites on the body. Sermorelin has no current FDA approval, so no approved instructions for use exist.¹⁰

Related pages

Reported effects and warnings: Sermorelin side effects. Doses used in studies: Sermorelin dosage. What studies found: Sermorelin benefits and uses. The 10 mg research vial: Sermorelin for sale.